The Italian Obstetric Surveillance System (ItOSS)

Perinatal mortality surveillance

The Italian Perinatal Surveillance System (SPItOSS), officially launched on 1 July 2017, is a pilot project coordinated by the Istituto Superiore di Sanità (ISS) in collaboration with three regions - Lombardy, Tuscany and Sicily - and funded by the National Centre for Disease Prevention and Control (Centro nazionale per la prevenzione e il controllo delle malattie - CCM) of the Ministry of Health. The project involves reporting incident cases of perinatal mortality and collecting information on the care procedures and organizational characteristics of the healthcare facilities where those deaths occur.

Its main objective is to implement an active surveillance model for producing population-based estimates of perinatal mortality and to gather useful information that may help prevent avoidable deaths.

Perinatal mortality: why monitor cases?

To help fight poverty and social inequalities around the world, the Millennium Development Goals (MDGs 2000-2015) [1] and the Sustainable Development Goals (SDGs 2016-2030) [2] have included the reduction of perinatal and child mortality among the priority actions of their programmes. In 2014, the United Nations adopted the WHO and UNICEF-led “Every Newborn” action plan [3], aimed at ending preventable stillbirths, maternal and newborn deaths around the world, and included stillbirths among its core indicators, alongside maternal mortality and neonatal mortality.

A dedicated series of papers in The Lancet revealed that substandard care accounts for 20%-30% of the phenomenon in countries with a high level of economic development, and that perinatal outcomes are also affected by non-clinical, and sometimes modifiable, factors, such as the mother living in conditions of social deprivation, cigarette smoking and alcohol consumption [4, 5].

Since 2011, Italy’s National Institute of Statistics (ISTAT) has been relying on two data sources to estimate the perinatal mortality rate: the D7a-Health for All monthly survey of vital demographic events, and the Survey on causes of death by region. The number of stillbirths obtained from these sources does not match that derived from the Birth Summary Certificate (Certificato di Assistenza al Parto - CEDAP) database. The difference in the number of stillbirths recorded in 2013, for example, was worthy of attention: 1236 (ISTAT) and 1362 (CEDAP database).

For the purpose of identifying perinatal deaths, their causes and risk factors, optimizing the quality of care received by mothers and newborns during labour, at birth and in the first week of life, and reducing preventable perinatal deaths, a prospective population-based surveillance system has been established to identify, notify and collect comprehensive and reliable data on incident cases.

Drawing on the experience of other countries, such as the United Kingdom [6, 7], which established obstetric surveillance systems monitoring both maternal and perinatal mortality, the SPItOSS pilot project extends the obstetric surveillance coordinated by the ISS to include perinatal mortality.

Methodology

SPItOSS collects data on perinatal deaths from all healthcare facilities with obstetric and neonatal units and/or neonatal intensive care units in regions Lombardy, Tuscany and Sicily. The objective is to extend the pilot project to the whole country, once it has been validated. Health professionals who provide childbirth care at these facilities are actively engaged in the project, reporting new cases of perinatal death. The surveillance system (based on the internationally adopted indicator) [8, 9] includes reporting and in-depth analysis of:

• Late intrauterine deaths (at 28 weeks of gestation or more)
• Early neonatal deaths (live-born infants dying within the first week of life).

As is the case with the maternal mortality surveillance, SPItOSS involves:

• The presence, at each healthcare facility, of a surveillance coordinator (facility coordinator) in charge of coordinating a multi-professional clinical audit to ensure a detailed assessment of any perinatal death. During the audit, which involves all healthcare workers who provided care for the infant who was stillborn or died within seven days of birth, the cause of death is established and comprehensive data on the case in question are collected anonymously
• Setting up a regional multi-professional committee of experts that, after receiving the audit data and anonymized clinical documentation from the facility coordinators, conducts confidential enquiries on a sample of incident cases to attribute the cause of death, evaluate its preventability and define the quality of care
• A central review by the ISS of the cases included in the confidential enquiries
• A critical analysis of the information gathered annually to develop recommendations for good clinical practice and interventions aimed at preventing avoidable deaths
• An annual dissemination of information at the national and regional levels
• An impact assessment of the actions taken

A strategic component of the active surveillance is the internal auditing performed at the facilities where deaths occur. An audit involves: identifying useful or harmful actions that have proved relevant to the outcome of a case; promoting a culture of transparency as the basis for improving care rather than blaming professionals; setting up a multi-professional peer group; supporting professional development based on the identification of group and individual needs for further education and training.

To establish the causes of intrauterine and early neonatal death, SPItOSS has adopted the International Statistical Classification of Diseases, Injuries and Causes of Death applied to perinatal mortality (ICD-PM) [9], which allows easier attribution of the cause of death by identifying the timing of death (antepartum, intrapartum and neonatal) and mutually exclusive clinical conditions that lead to the determination of a single cause of perinatal death. ICD-PM also helps highlight the correlation between maternal and perinatal conditions, identifying the maternal factors that contributed to the death.

Work and educational material

• The operating protocol of the project was presented during the first meeting of the national project Steering Committee, on 13 June 2017. View the slides (pdf 3.2 Mb, in Italian) of the presentation, the composition of the Steering Committee (pdf 267 kb, in Italian) and the short protocol of the project (pdf 391 kb, in Italian).
• Educational material for cascade training can be downloaded from Google Drive here: Lombardy (in Italian), Tuscany (in Italian), Sicily (in Italian).

References

1. A/RES/55/2: United Nations Millennium Declaration: resolution adopted by the General Assembly. 55/2. Sept 8, 2000.
2. A/RES/70/1 - Transforming our world: the 2030 Agenda for Sustainable Development
3. WHO, UNICEF 2014. Every Newborn: an action plan to end preventable deaths. Geneva: World Health Organization
4. The Lancet Ending preventable stillbirths Series 2016:
5. Lawn JE, Blencowe H, Waiswa P, et al. Lancet Ending Preventable Stillbirths Series study group; Lancet Stillbirth Epidemiology investigator group. Stillbirths: rates, risk factors, and acceleration towards 2030. Lancet 2016; 387(10018):587-603
6. Ward Platt M. The MBRRACE-UK perinatal surveillance report. Arch Dis Child Fetal Neonatal Ed. 2016.101(1):F4-5.
7. World Health Organization. Maternal, newborn, child and adolescent health. Stillbirths,
8. World Health Organization. Maternal, newborn, child and adolescent health. Stillbirths,
9. The WHO application of ICD-10 to perinatal deaths: ICD-perinatal mortality (ICD-PM). Geneva: World Health Organization.
10. Flenady V, Wojcieszek AM, Middleton P, et al. Lancet Ending Preventable Stillbirths study group; Lancet Stillbirths In High-Income Countries Investigator Group. Stillbirths: recall to action in high-income countries. Lancet 2016 13;387(10019):691-702
11. Il documento congiunto (2014) “UN Inter-agency Group for Child Mortality Estimation. Levels and trends in child mortality”